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Maria Stella Graziani

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Martina Zaninotto

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Ferruccio Ceriotti
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International Advisory Board Khosrow Adeli Canada
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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

BC: Articoli scritti da M. Gion

Raccomandazioni per l'implementazione del Test genetico BRCA1/2 nelle pazienti con carcinoma ovarico: dall'analisi sul tessuto tumorale a quella su DNA germinale.
Recommendations for the implementation of BRCA1/2testing in ovarian cancer patients: from tumor togermline analysis. Joint document from SIBioC, AIOM, SIGU, SIAPEC-IAP
<p>Since the approval of the first polyadenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi), olaparib for platinum-sensitive relapsed highgrade ovarian cancer, with either germline or somatic BRCA1/2deleterious variants, the strategies for BRCA1/2testing are dynamically changing. In fact, along with germline assay, patients are now tested for tumor BRCA1/2alsoabove all for treatment decisions. In fact, it is reported as by tumor BRCA analysis we can identify 3&ndash;9% moremutated women which can therefore benefit from PARPi therapy. Although this new type of approach looks likechallenging, in particular due to the technical and analytical difficulties regarding low quality DNA deriving fromformalin-fixed paraffin-embedded specimens, the new CE-IVD on NGS-based pipelines, can overcome these issues,allowing specialized molecular laboratories to ensure high quality results and perform the best test settings.Nevertheless, each new NGS pipeline (CE-IVD or in house) should be validated using peculiar samples along withcommercially available reference and certified materials, before being introduced in routine settings. The validationset should be appropriately chosen in order to provide unequivocal data regarding robustness of each NGStBRCApipeline. Therefore, in order to harmonize the patient and laboratory path, a group of Italian Scientific Societies[Italian Society of Clinical Chemistry (SIBioC), Italian Association of Medical Oncology (AIOM), Italian Association ofClinical Pathology (SIAPEC), Italian Society of Human Genetics (SIGU)] provided the present recommendationswhich are aimed to guide all professionals (oncologists, gynaecologists, clinical and laboratory geneticists, clinicalmolecular biologists and pathologists). The intersociety group is confident that the present paper can offer all ovariancancer women a well-organized pathway of diagnosis and treatment.</p>
Biochimica Clinica ; 43(3) 332-338
Documenti SIBioC - SIBioC Documents
Antigene prostatico specifico, screening del cancro della prostata, linee guida e il giudice saggio
PSA, prostate cancer screening, clinical practice guidelines and the “wise judge”
M. Gion  | 
<p>PSA, prostate cancer screening, clinical practice guidelines and the &ldquo;wise judge&rdquo;. PSA appeared since its earliest clinical use to be a promising tool for the early detection of prostate cancer (PCa) and several studies investigated its effectiveness in the screening of asymptomatic men. Three large randomized controlled trials involving 654,293 men, performed over the last 25 years, have been completed and results are now available. Two trials showed that PSA screening lead to an estimate of approximately 1 prostate cancer death avoided every 1000 men screened. The third, more recent, trial did not show any significant effect on PCa mortality after a 10 year follow-up. PSA screening also led to a risk reduction of 3 metastatic cases per 1000 screened men, but these findings did not reflect in a reduction of PCa specific mortality. The three studies confirmed a very high rate (50%) of overdiagnosis of indolent cancers, that increased the frequency of biopsy related complications and side effects due to treatments (incontinence, impotence, bowel dysfunction). In summary, benefits of PSA based screening of PCa are still debated while harms are established. A systematic search for clinical practice guidelines (CPG) published over prior 5 years identified 12 pertinent documents. CPGs unanimously agreed in recommending against PSA-based mass screening for PCa as a public health policy. Conversely, positions of CPGs are mixed concerning PSA for opportunistic screening: some CPGs recommend against, others recommend that an individualized risk-adapted strategy for early detection should be offered to well informed men with good performance status and 10-15 years of life expectancy. The comparative synopsis of CPGs shows the variability of decision-making in relation to the clinical problem and/or the context and offers to the physician the opportunity to &ldquo;wisely&rdquo; discuss with the patients all the possible choices supported by evidence.</p>
Biochimica Clinica ; 42(4) 321-326
Opinioni - Opinions
Biomarcatori nella diagnosi del carcinoma dell’ovaio: dialogo fra un patologo clinico e un ginecologo oncologo
Biomarkers in the diagnosis of ovarian cancer: a dialogue between a clinical pathologist and a gynecologic oncologist
M. Gion  |  T. Maggino  | 
<p>&nbsp;A general consensus exists on the effectiveness of CA125 in ovarian cancer management, where it is&nbsp;currently used as an aid in clinical decisions for the initial work-up, post-operative follow-up and for monitoring&nbsp;chemotherapy in advanced disease. It is, however, apparent that no effective marker is presently available for costeffective&nbsp;screening of asymptomatic population. The debate is still open on the role of markers in the differential&nbsp;diagnosis of adnexal masses and some agreement exists on the following issues: 1) the referral to a gynecologic&nbsp;oncologist improves outcome for ovarian cancer patients, including overall survival; 2) markers should not be&nbsp;intended as a cancer diagnostic test, but as one of the criteria for the selection of patients with adnexal mass at a&nbsp;higher cancer risk; 3) CA125 appears to have several shortcomings: low sensitivity for early stage disease and low&nbsp;specificity, especially in premenopausal women; 4) algorithms combining CA125, age and imaging to assess the risk&nbsp;of a mass being malignant improve diagnostic accuracy of CA125 used alone; 5) among novel markers, HE4 has&nbsp;emerged as the most effective, overperforming CA125 mainly in premenopausal women; 6) mixed data have been&nbsp;reported on the advantages of ROMA, a diagnostic algorithm integrating HE4, CA125 and menopausal status, vs.&nbsp;HE4 alone; 7) conflicting data suggest that properly designed and well performed studies are still needed to identify&nbsp;the most effective diagnostic approach to assess cancer risk in patients with adnexal mass.</p>
Biochimica Clinica ; 37(3) 208-213
Opinioni - Opinions
Confronto tra due metodi per la misura nel siero della proteina 4 dell’epididimo umano (HE4) nella diagnosi di carcinoma ovarico
Comparison between two methods for the determination of serum human epididymis protein 4 (HE4) in the diagnosis of ovarian cancer
<p>Analytical performance and diagnostic accuracy of two commercial immunoassays for&nbsp;the determination of HE4 in the diagnosis of ovarian cancer were evaluated. HE4 was determined on sera&nbsp;consecutively obtained from 205 women (163 with benign ovarian or adnexal disease and 42 with ovarian cancer) by&nbsp;using a manual EIA (Fujirebio Diagnostics, Inc.) and an automated chemiluminescent microparticle assay (CMIA)&nbsp;(Abbott Architect platform). The intra- and interassay imprecision for EIA and CMIA was satisfactory (CV &lt;10%). The&nbsp;linearity test showed recovery values between 86% and 120%. Comparison analysis showed an acceptable&nbsp;agreement between the two methods (r=0.99), with an average bias of 1.2%. ROC curve analysis showed an area&nbsp;under the curve of 0.893 for EIA and 0.899 for CMIA, respectively. Setting the specificity of each assay at 95% (cutoff,&nbsp;102,7 pmol/L for EIA and 101,8 pmol/L for CMIA), the sensitivity for both methods was 67%. Both EIA and CMIA&nbsp;appear reliable for clinical application.</p>
Biochimica Clinica ; 37(3) 200-207
Contributi Scientifici - Scientific Papers
Guida all’uso clinico dei biomarcatori in oncologia: le prospettive
Guidelines for clinical use of biomarkers in oncology: an outlook
<p>Although much information has recently been accumulated in the field of biomarkers, no new markers have been approved by the U.S. Food and Drug Administration for clinical use over the last two decades. This fact emphasizes the need to strengthen translational research in order to select, evaluate, and validate the most promising biomarkers in a reliable and efficient manner. The most innovative development regarding traditional markers is in their dynamic assessment in the diagnostic scenario. This approach is under evaluation for several biomarkers, e.g. PSA for prostate cancer and CA 125 for ovarian cancer. On the other hand, new biomarkers are under study. Some promising biomarkers, such as the antibody immune response indicators, mechanism and/or microenvironment associated markers, and circulating tumour cells, are already in the validation phase. Even if they have preliminarily demonstrated very high potential, there is however insufficient evidence to support their definitive clinical use.</p>
Biochimica Clinica ; 36(1) 40-45
Documenti - Documents
Guida all'uso clinico dei biomarcatori in oncologia: i marcatori nelle diverse neoplasie - Parte II
Guidelines for clinical use of biomarkers of different neoplastic diseases - Part II.
<p><strong>Guidelines for clinical use of biomarkers of different neoplastic diseases &#8211; Part II.</strong> This contribution represents the second of two parts of guidelines for clinical use of tumour biomarkers, reporting in schematic tables the evidencebased information available for different neoplastic pathologies (the first part was published on Biochim Clin 2011;35:394-403). Particularly, the following neoplastic conditions are considered in this document: testicular seminoma and non-seminoma, cervical uterine cancer, ovarian and renal cell carcinomas, breast cancer, melanoma, and neuroendocrine tumors.</p>
Biochimica Clinica ; 35(6) 465-473
Guida all'uso clinico dei biomarcatori in oncologia: i marcatori nelle diverse neoplasie - Parte I
Guidelines for clinical use of biomarkers in different neoplastic diseases - Part I.
Biochimica Clinica ; 35(5) 394
Guida all'uso clinico dei biomarcatori in oncologia: metodologia e chiave di lettura
Guidelines for clinical use of biomarkers in oncology: methodology and reading key
Biochimica Clinica ; 35(4) 307
Guida all'uso clinico dei biomarcatori in oncologia: metodi di misura e interpretazione
Guidelines for clinical use of biomarkers in oncology: methods and interpretation
Biochimica Clinica ; 35(3) 199
La Guida all'uso clinico dei biomarcatori in oncologia 2010
Guidelines for clinical use of biomarkers in oncology
M. Gion  | 
Biochimica Clinica ; 35(2) 89
EDITORIALE - Editorial
La Guida all'uso clinico dei biomarcatori in oncologia 2010: premesse e generalità
Guidelines for clinical use of biomarkers in oncology: premises and introductory concepts
M. Gion  | 
Biochimica Clinica ; 35(2) 97
DOCUMENTI - Documents